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Guidelines for Large Scale Novel H1N1 Influenza Vaccination Clinics Introduction This document provides general guidance and examples for planning and conducting large-scale immunization clinics. Incorporated into the document is information specific to influenza vaccination clinics during a pandemic. At present, given that there are many unknowns about novel H1N1 influenza, planning at the state, local and clinic levels should be flexible and build around varied scenarios This document covers important topics such as clinic settings, clinic flow, staffing functions, administration and storage of vaccine, clinic supplies and equipment, security, documentation, post-vaccination observation, handling and disposal of needles 1. Determine Resource Needs Based on the vaccination strategy (i.e., priority groups, disease severity and prevalence, seasonal flu patterns, etc.) the number and duration of clinics, and number of staff required should be calculated. The precise number of personnel needed for any one clinic will vary, however, depending on the size and layout of clinic facilities, location of clinic, geographic area being served by the clinic, estimated number of vaccine recipients at each clinic. The over- all staffing needs should be estimated based on the model described under Section 1: Clinic Operations 2. Identify Potential Clinic Sites Potential clinic sites should be selected based on the estimated number of people expected to be served and the size and layout of the facility. The size and type of facilities needed for novel H1N1 influenza immunization clinics will vary depending on the number of persons to be served. Small clinics, such as those to immunize health care workers, can be conducted in almost any available space, most likely a local health department, hospital occupational clinic, or similar facility. Larger clinic sites could be housed in schools, churches, industrial locations, office buildings, or apartment complexes. Schools may be the preferred location for any clinic required to be larger than a local health department. Schools have parking lots, long corridors, large classrooms, gymnasiums, cafeterias, private offices, and other immediately available resources, such as tables and chairs, and offer an ideal physical structure that can meet most clinic needs. Elementary schools are preferable because they are numerous and serve fairly well- defined neighborhoods convenient to the public. The use of middle or high schools may also be considered. In selecting clinic sites, handicap access must be assured. Also, consideration should be given to ensuring a smooth flow of clients, accessibility of the facility to major streets, restroom facilities, parking, refrigeration, heating/air conditioning, protection from the elements, personal and client safety and security. Before final selection, a visit should be made to the location to ensure that the facility meets the needs of the vaccination operation. 3. Obtain Authorization / Standing Orders Before a clinic can be implemented, standing orders must be obtained from the public health authority, usually the state and/or local health officer to provide authorization for administration of the influenza vaccine. Standing orders are also needed for responding to medical emergencies that occur during vaccination clinics, ranging from minor injuries and illnesses to anaphylactic shock. In addition to providing standing orders, the health officer or his/her designee must approve the content of informational materials and serve as medical consultants for nursing and other staff.

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Page 1: Guidelines for Large Scale Novel H1N1 Influenza ... · The size and type of facilities needed for novel H1N1 influenza immunization clinics will vary depending on the number of persons

Guidelines for Large Scale Novel H1N1 Influenza Vaccination Clinics

IntroductionThis document provides general guidance and examples for planning and conducting large-scale immunization clinics. Incorporated into the document is information specific to influenza vaccination clinics during a pandemic. At present, given that there are many unknowns about novel H1N1 influenza, planning at the state, local and clinic levels should be flexible and build around varied scenarios

This document covers important topics such as clinic settings, clinic flow, staffing functions, administration and storage of vaccine, clinic supplies and equipment, security, documentation, post-vaccination observation, handling and disposal of needles

1. Determine Resource NeedsBased on the vaccination strategy (i.e., priority groups, disease severity and prevalence, seasonal flu patterns, etc.) the number and duration of clinics, and number of staff required should be calculated. The precise number of personnel needed for any one clinic will vary, however, depending on the size and layout of clinic facilities, location of clinic, geographic area being served by the clinic, estimated number of vaccine recipients at each clinic. The over-all staffing needs should be estimated based on the model described under Section 1: Clinic Operations

2. Identify Potential Clinic SitesPotential clinic sites should be selected based on the estimated number of people expected to be served and the size and layout of the facility. The size and type of facilities needed for novel H1N1 influenza immunization clinics will vary depending on the number of persons to be served. Small clinics, such as those to immunize health care workers, can be conducted in almost any available space, most likely a local health department, hospital occupational clinic, or similar facility. Larger clinic sites could be housed in schools, churches, industrial locations, office buildings, or apartment complexes. Schools may be the preferred location for any clinic required to be larger than a local health department. Schools have parking lots, long corridors, large classrooms, gymnasiums, cafeterias, private offices, and other immediately available resources, such as tables and chairs, and offer an ideal physical structure that can meet most clinic needs. Elementary schools are preferable because they are numerous and serve fairly well-defined neighborhoods convenient to the public. The use of middle or high schools may also be considered.

In selecting clinic sites, handicap access must be assured. Also, consideration should be given to ensuring a smooth flow of clients, accessibility of the facility to major streets, restroom facilities, parking, refrigeration, heating/air conditioning, protection from the elements, personal and client safety and security. Before final selection, a visit should be made to the location to ensure that the facility meets the needs of the vaccination operation.

3. Obtain Authorization / Standing OrdersBefore a clinic can be implemented, standing orders must be obtained from the public health authority, usually the state and/or local health officer to provide authorization for administration of the influenza vaccine. Standing orders are also needed for responding to medical emergencies that occur during vaccination clinics, ranging from minor injuries and illnesses to anaphylactic shock. In addition to providing standing orders, the health officer or his/her designee must approve the content of informational materials and serve as medical consultants for nursing and other staff.

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4. Plan TrainingAll public and private health care workers and the many volunteer workers who may become involved in influenza vaccination efforts should receive both job specific and, where possible, cross job training in advance and/or on the job. Large numbers of clinic staff can be trained using a train-the trainer approach.

5. Publicize the ClinicAfter immunization clinic locations are determined and recipient populations identified, public announcements with information about these clinics should be released as soon as possible.

When developing communications materials, all relevant information should be included. As decisions are made, the information disseminated must clearly describe the groups for whom the clinic is intended or not intended. For example, certain locations might serve priority groups exclusively. Non- English speaking groups may be asked to come at specific dates and times when translator resources are available. Information identifying clinic locations and directions, dates and times of operations, length of time the vaccination process may take, tips on type of clothing to wear, and what to expect once at a clinic should be provided through various media outlets (TV, newspapers, etc.) in as many languages as needed.

The CDC’s education and communication materials will be made available electronically and in printed formats. When available they should be translated into the appropriate languages for the geographical area, reproduced in appropriate quantities and ready for rapid distribution. Patient education materials may need to be modified in consultation and coordination with immunization partners and representatives of the community to ensure that the information provided is adequate and culturally appropriate for local audiences. Printed materials should be at reading levels suitable for their intended audiences.

Using professional public relations assistance when available, announcements should be updated from the CDC materials and released for television, radio, and newspaper media. If specific groups require additional information, (e.g., to counteract misconceptions about vaccination) clinic organizers may need to distribute flyers to targeted populations in apartment buildings, neighborhoods, workplaces, schools, and/or religious centers.

If special transportation can be provided for persons with physical or age-related disabilities, the telephone number for requesting special transportation should be included in all clinic publicity. To ensure accurate reporting by the media a list of subject experts and media spokespersons from state and local public health agencies and community partners should be developed and made easily accessible to the media through an approved format. If necessary, individuals who can be called upon to serve as interpreters should be identified to help inform non-English speakers. This list should note the foreign languages spoken by these individuals. To improve understanding of the subject matter, photographs and graphics should be provided in various media.

In addition to information about the specific clinic being publicized, a concerted effort should be made to provide information to the public that emphasizes:

• The rationale of the immunization strategy. • Disease containment measures are effective. • All possible measures are being taken to prevent the further spread of the disease.

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Section 1: Clinic operations

1. The Vaccination Clinic ProcessStep One: OrientationAs vaccine recipients arrive, they are routed to the clinic entrance by security personnel who are handling outside traffic flow and parking. Staff will screen patients for signs and symptoms of an influenza-like illness (ILI). Clients who present with symptoms of an ILI will be directed to an alternative section of the clinic. Well-clients enter the clinic building vaccine and are directed to a location where the greeter-educator briefs groups about what is going to take place during the clinic process and hands out paperwork for the client to fill out. Clients will begin to read and fill in required personal information (name, address, etc.) Multiple educator-greeters locations may be necessary to accommodate the rate at which people arrive.

Step Two: Form Completion and Assessment for ContraindicationsClinic flow coordinators direct vaccination clients to tables where staff is available to answer questions and aid clients in completing required forms. Vaccine clients who check ‘yes’ for allergy to eggs and/or previous problems following a previous influenza vaccinations are directed to a separate station where a medical professional will complete a more in-depth evaluation.

Step Three: VaccinationVaccine clients with no medical contraindications are directed to the vaccination area. This area is a screening area that affords privacy to persons who find it necessary to remove clothing in order to expose the vaccination site. A vaccination assistant helps vaccine recipients expose their vaccination site (upper arm, thigh) and cleans the vaccination site if necessary. The vaccine administrator then administers the vaccine and the assistant applies a bandage to the vaccination site. The patient’s clinic documents and a patient-held vaccination card are completed.

Step Four: Post Vaccination Observation, Clinic Forms Collection and ExitThe vaccine recipients are routed to an area set aside to be observed for 10-15 minutes for potential post-vaccination problems. During this time the clinic forms collector ensures that forms are complete, answers any remaining questions and informs vaccine recipients that they will need a second vaccination or are finished with the process, as appropriate. This individual also ensures that the vaccinee has been provided a completed vaccination card.

2. Staffing and TrainingThe official responsible for overall direction of the vaccination operation must assign a clinic manager who is responsible for overall clinic operation. This is the primary decision maker for the site, and supervises all non-medical personnel. All staff and volunteer assignments should be documented on a clinic assignment sheet.

Management and Coordination FunctionsTo assist the manager with large clinic operations, coordinators should be identified for the various clinic functions as outlined below:

Nurse Coordinator: Oversees nursing staff assigned to the clinic; assists clinic manager in making clinic assignments for nursing staff; assists on-duty nurses as needed.

Supply Officer/ Vaccine Manager: Ensures that all necessary clinic supplies are on site and are available in sufficient quantities during clinic operations; ensures vaccine supply and orders vaccine; tracks vaccine supply at the beginning and end of each day, maintains an inventory of supplies; oversees distribution of supplies to appropriate locations in the clinic; ensures that the vaccine is maintained properly (refrigeration, vaccine monitoring) and in a secure manner at the clinic site; accounts for unused vaccine;: very importantly, maintains adequate vaccine and other supplies at the vaccine station; and ensures that ‘sharps’ containers and other waste are disposed of appropriately.

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Security Coordinator: Oversees personnel assigned to security activities at the clinic site; assists the clinic manager in making duty assignments of security personnel; determines appropriate number of security staff necessary according to clinic size and location; maintains a list of authorized clinic staff and their phone numbers; assigns and coordinates use of cell phones and pagers; establishes staff check-in and check-out procedures; ensures that all staff wear ID badges; maintains communication with local law enforcement officials.

Volunteer Coordinator: Oversees volunteer activity at the clinic site. Assists the clinic manager in making duty assignments of volunteer staff; maintains roster of persons available for volunteer duty; and maintains a schedule of times that volunteers will be available to work.

Staff FunctionsFollowing is a summary of suggested responsibilities of the staffing roles as outlined in the operational concept above:

Clinic Screeners: Screeners intercept clinic clients outside the clinic area and separate clients presenting with signs and symptoms of influenza-like illness from well clients. They direct well clients into the clinic area and ILI patients to an alternate area.

Greeter-Educators: Greet and conduct initial orientation of potential vaccine recipients upon their arrival; provide basic information about the vaccine and the vaccination process; distribute informational material and clinic documents and answer questions.

Greeter-Educators must be able to explain the purpose of receiving the vaccine, outline the vaccination clinic process, and distribute and explain the clinic documents to vaccine recipients.

Forms Completion Assistants/ Contraindication Assessment Staff: Assist and review each vaccine client’s documents for completeness, accuracy, and address those that answered, “yes” to any questions that concerns contraindications to influenza vaccine.

These staff must be familiar with the content of each form. They must be prepared to respond to exceptional situations such as non-English speaking patients or patients who are anxious, hostile, disoriented or physically disabled. The documentation staff will aid clients in completing all forms accurately. They should be prepared to read the forms to illiterate or semiliterate persons needing their assistance. If a “yes” is indicated by the client in a question concerning a contraindication to an influenza vaccine, the staff directs the client to the medical station.

Medical Evaluator: Medical personnel further evaluate clients who indicate they might have a contraindication, provides medical aid to vaccinees experiencing medical problems following vaccination, and participates in further evaluation of clients who presented with ILIs.

This role should be filled by a physician, nurse or paraprofessional who is well-versed in contraindications to vaccination and the risks of influenza disease. The medical evaluator will review in greater detail the specified contraindication with the client and will assist in making a final decision about whether or not to vaccinate.

Medical personnel must be able to respond to emergencies, including reactions ranging from the minor to anaphylactic shock and serious medical emergencies that are incidental and unrelated to vaccination but can be expected to occur whenever large groups of people congregate. For large operations, a physician, physician’s assistant, nurse practitioner or emergency medical technician should be on-site at all times during clinic operations.

Vaccination Assistants: Assist the vaccine administrator with all aspects of pre-and post-vaccine administration activities; preload syringes; prepare nasal spray units; ensure that vaccination station maintains adequate supplies; at site of vaccination, assist vaccine recipients in preparing the vaccination site ( roll up sleeves, remove arm from shirt/blouse, expose thigh, etc.); clean vaccination site with alcohol, if necessary; apply bandage to the vaccination site; ensure that “sharps” containers and other waste materials are correctly handled and disposed of, and help complete clinic forms.

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Vaccination assistants must have a thorough understanding of the vaccination process and the necessary supplies, proper technique for preparing the vaccines; filling a syringe with the exact dose, preparing nasal spray units; proper care and handling of vaccine in the clinic, how to disinfect contaminated surfaces and dispose of soiled materials, and where to access additional supplies. Vaccination assistants are also responsible for entering the vaccine lot numbers and other required information onto the patients’ clinic record and personal vaccination card. Finally, the assistant directs the patient to the post-vaccination observation area.

Vaccine Administrators: Oversee the immunization process; determine appropriate type (inactivated, injectable or live, attenuated, nasal spray) and dose volume (child or adult) of vaccine: administer the vaccine; appropriately dispose of “sharps” containers, sign the clinic record (if required) and observe vaccine recipients in the post-vaccination observation area for reactions or complications.

Vaccine administrators can be RNs, physicians, LPN, MAs or designated paraprofessionals (according to individual state rules/regulations) who have received technical training in administration of each type of influenza vaccine (inactivated, injectable and live-attenuated, nasal spray). Vaccinators must have training to be able to quickly select the appropriate type of vaccine to administer based on clients’ age. They must have in-depth people skills, and understanding of proper vaccination techniques, methods to prevent contamination of the vaccine, preparation of the vaccination site and normal and abnormal post vaccination responses. Vaccinators must also be prepared to recognize, respond to and alert emergency medical personnel of possible post vaccination reactions and other medical emergencies that occur within the vaccination area.

Forms Collectors: Answer client questions, verify that forms are correctly completed; collect all necessary forms from recipients before departure.

The forms collector is responsible for checking that the vaccination team has signed the clinic record (if required) and entered the lot numbers on the appropriate documents. As the last staff to have contact with the vaccine recipients, the forms collector must have the ability to ensure a response by the appropriate staff to any remaining concerns those clients may have.

Clinic Flow Controllers: Direct vaccine clients through the clinic process and monitor clinic flow.

Clinic flow coordinators are responsible for continuously monitoring and directing client activity throughout the facility. They must be able to calmly manage and assist people who may be anxious and unable to follow directions. When congestion (backlog) is noted, flow controllers determine if staff at other locations are less busy and request assistance in the congested area. They are also responsible for feeding back information about the number and rate of upstream clients to the vaccination assistants to enable them to maximize use of all vaccine doses in opened vaccine vials. Flow controllers may be in a position to provide early alert of situations that may require additional security personnel.

Security Staff: Ensure an orderly flow of traffic and parking at the clinic site; assist in maintaining orderly movement of vaccine recipients through the clinic process; provide necessary control if persons become unruly; assist supply officer in maintaining security of vaccines and other clinic supplies.

Security Staff can be off-duty law enforcement officers, professional security personnel and/or volunteers who are experienced and trained in crowd control. Potential responsibilities of security staff are described in detail below (under Security).

Staff TrainingThe staff operating a clinic site should receive a group orientation about the overall purpose, function, and flow of the vaccination clinic, as well as specific verbal and written directions for their individual roles. During the orientation a diagram with annotations should be provided to show traffic flow, the functions of all clinic stations and a list of staff assigned to each role and each station, if possible. The responsibilities of each area of the vaccination clinic are reviewed with the entire staff. All staff need to know where they will work, where supplies and resources are located, and who their consults are as well as how to summon them. Daily post-clinic debriefings should be held to assess staff performance and ascertain if additional training or clinic reconfiguration is needed.

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In small clinics staff roles can be flexible to accommodate changes in clinic flow and patient numbers, and to permit rest breaks for other staff. In large clinics this, and accommodating unexpected staff absences, can be accomplished by cross training of staff. Therefore, orienting staff in small, interchangeable teams is suggested.

If time permits, a mock vaccination clinic or role playing session should be conducted to train and evaluate the potential performance of staff. Vaccinating clinic staff, as well as first responders and other health providers, is suggested as a way to provide critical training and experience for all staff, especially the vaccine administrators.

Emergency personnel should also attend the group orientation and be given information about influenza. They should be familiar with the layout of the clinic site and know where ill patients will be maintained prior to transport.

3. Clinic Layout and FlowClinics should have clearly marked entrance and exit points with adequate “waiting” space for queues of people seeking vaccination. Security staff should be posted at both locations to maintain order. The traffic flow within the clinic should be controlled and should follow a logical path from entry into the clinic to exit from the clinic. A linear path of traffic flow from entry to exit on opposite sides of the facility is optimal. If time permits, easy-to-read signage should be provided to guide people through the clinic process. (See – Example of Large Scale Influenza Vaccination Clinic below.)

One or more persons (screeners) should ask about, and monitor clients for signs and symptoms of influenza-like illness (ILI) while outside the entrance to the clinic. All persons presenting without such ILI signs and symptoms should proceed into the clinic. Those found to have symptoms of ILI should be directed to a set-aside alternative area for a more detailed medical evaluation.

Within the clinic, greeter-educators provide information to clients on clinic procedures and hand out clinic forms for completion of Vaccine Information Statements (VISs) and other materials. A separate area should be provided in which clients can be seated to complete forms, and staff member are available to answer questions and assist in the completion of client forms. Medical providers are available to interview clients with histories of contraindications to influenza vaccine. All this should be performed in an area separate from the vaccine administration stations.

It is likely that form completion will become the most time-consuming clinic activity. Sufficient staff should be assigned to move persons through these areas with some dispatch in order to maintain a steady flow of clients to the vaccination areas and maximize the efficiency of the vaccinators. Client overflow should be held in a location in the clinic designated for this contingency.

Traffic in the area where vaccine is being administered should be kept to a minimum. Ideally, each vaccination station should be physically organized so that clients must present one at a time at the vaccine administration table. The three steps of the actual vaccination process (site preparation, vaccination, and dressing application) shared by the vaccination team will take place in a relatively small space (one or two tables) in the same area. Since some vaccine recipients may need to remove shirts or blouses in order to be vaccinated, a separate, screened privacy area should be available out of view of other persons awaiting to be vaccinated. If possible, a separate vaccination station should be opened for the elderly and persons with disabilities who may need additional time.

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Example of Large Scale Influenza Vaccination Clinic

1

2

3Tables

&Chairs

forFillingOut

Forms

Medical and OtherStaff to

Answer Questions

Form Completion Area — Multiple Stations

Post-Vaccination Observation Area

Client Waiting Area(Education, Communication and Form Distribution)

Staff Greetand Guide Clients

CLINICENTRANCE

Screening Area

ScreenersOutside

Clinic Area

EXIT AlternativeClinic Section

NON-SYMPTOMATIC SYMPTOMATIC

4Staff Directs Clients to Vaccination Lines

5Staff Directs Clients toVaccination Stations

Vaccinators and Assistantsat Each Station

Runners to KeepVaccinators and Assistants

Supplied

6

7

8 Form Collectors 9 Staff DirectsVaccinated

Clients to Exit

CLINICEXIT

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The clinic vaccination record for each vaccine recipient should be completed and verified. The recipient should also be provided with a personal vaccination card.

The post-vaccination observation area and medical emergency area should be located as close to the vaccine administration area as possible.

4. Documentation and PaperworkVaccinee-specific documents that may be required by a novel H1N1 influenza immunization clinic must be collected (Table 1.). The clinic vaccination record of each recipient must be retained by the clinic in paper or electronic format. If computer resources are available, required recipient clinic data should be entered in “real time” throughout the vaccination process. However, paper-based documents may be the only available collection format. Where possible, these can then be entered into a computer for storage and to provide a summary.

Certain administrative documents and worksheets, such as staffing assignments, attendance, doses available, administered and wasted, will be required to assist in clinic management and keeping track of the vaccine (Table 2.).

5. SecurityEarly in the vaccination program, especially if influenza cases are many, severe and rapidly increasing in number and vaccine availability is not well defined, the level of risk perceived by the public may be extreme. In these circumstances, state and local public health officials should be prepared for a high level of demand for vaccine by the public. Likewise state, local and contract law and security agencies should be prepared for traffic and crowd control near vaccination clinics.

Management ResponsibilitiesThe clinic manager must ensure that the following activities are handled at each site: • Notify state/local police and EMS of the time location of the clinic • Assign a security coordinator • Ensure presence of police of other security personnel • Require that all staff wear identification cards • Determine need for trained security guards, crowd control and traffic control personnel • Designate entrances/exits for staff use • Provide list of authorized staff for each clinic site • Establish staff check-in/check out procedures • Establish methods and locations to safeguard vaccine and other clinic supplies • Maintain a system to vaccinate clients in their order of arrival

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TABLE 1

POSSIBLE VACCINATION DOCUMENTS

Document Information Collected Or Provided

How Used

Screening Protocols:a)ILI symptomsb)Contraindicationsc)Prioritization

Symptoms of ILI or notContraindications to Flu Vaccine or ComponentsPriority Group

>Screen ILI suspects from enteringclinic

>Identify/send to medical personfor expert opinion

>Ensure vaccination of highpriority groups first

Vaccine Information Statement and/or EUA Fact Sheet (if required)

Verbal: Yes/No: Have you read? Do you understand? VAERS instructions

Provide disease and vaccine information at clinic; Taken home by vaccinee to inform/advise how to report adverse events to VAERS

Clinic Vaccination Record Name, Address, Date age/DOB,M/F, lot number, manufacturer, type of administration (injection/ nasal), other state, local, and clinic- required data

Official clinic medical record retained and available for VAERS review and/or FDA/CDC review under EUA

Patient Vaccination Card Name, Clinic Name and phone, Date age/DOB,M/F, lot number, manufacturer, type 1st dose, 2nd dose, date to return for 2nd dose

Proof of vaccine receipt; Information presentable to health provider in the advent of an Adverse Event; Reminder/recall for 2nd dose and date for 2nd dose verify receipt of vaccine

TABLE 2POSSIBLE ADMINSTRATIVE WORKSHEETS

Document Information Collected Or Provided How Used

Daily Vaccine Tracking Record By:• Inactivated types • Life, attenuated type

• Beginning Inventory • Dose received • Doses Administered • Ending Inventory • Doses Wasted Signature of clinic official

Documents where, when and how much vaccine was used; daily vaccine supply monitoring, accountability

Staffing/Volunteer Assignment Sheet

Date of Clinic Clinic Roles Individuals Assigned Attendance

Record staffing/volunteer assignments

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Security Staff ResponsibilitiesSecurity staff functions include: (1) maintaining orderly clinic operations; (2) protecting patients; (3) protecting employees; (4) protecting facility property, including medical supplies and vaccine; and (5) enforcing the direction of ILI symptomatic clients to an alternative section of the clinic. To fulfill these functions, security staff must have the capacity to: • Manage the facilities’ security resources. • Monitor the physical facility. • Recognize potential for mob behavior. • Control access to the facility and areas within it... • Provide a means to identify authorized employees. • Update an authorized personnel list on an ongoing basis. • Coordinate with other security agencies. • Direct person in need of care to alternative facilities. • Remove individuals who pose a risk to the facility and its operation. • Follow the emergency response plan of the state, local and/or facility. • Communicate with clinic staff, the command center, and external security personnel. • Perform a secure lock down of the facility quickly. • Obtain additional security resources in a predefined “emergency” situation. • Respond with appropriate force if required. • Provide information to persons massed outside the facility.

Security StrategyTo manage a large number of people arriving at clinic sites, the main strategy should be to 1) secure a limited access perimeter at a designated distance from the physical facility; 2) secure the clinic itself (interior perimeter; e.g., the facility’s main and secondary entrances, front drive, and parking area); and 3) maintain order within the facility. To carry out these strategies, security personnel must be prepared to:

• Intercept and detain individuals attempting unauthorized entry to the facility. • Continuously provide situation information to state/local disaster command and control. • Disseminate public information, including leaflet distribution. • Control and disperse crowds. • Operate available security equipment such as closed circuit television, metal detectors, security alarm systems and radio communications system.

Emergency ProtocolIn a medical or public safety emergency, security staff should immediately undertake the following activities:

• Set up an outer perimeter • Arrange to meet emergency vehicles at the outer perimeter and guide them to the appropriate entrance. • Meet mass transit and supply vehicles at the outer perimeter and direct them to the appropriate entrance. • Meet individuals coming to the facility at the outer perimeter and identify them as either authorized staff or eligible for care. • Deny ineligible or unauthorized persons admission using standard scripts.

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• Direct authorized persons to the admission station at the interior perimeter. Offer disabled persons, the elderly, and parents with small children an escort, when appropriate. • Monitor length on lines at the clinic entrance and relay information to the outer perimeter to limit admission, when necessary. • Refer over-flow to other clinics, if necessary. • Lock down the facility in the event the security objectives were compromised.

6. Clinic Supplies and EquipmentA secure area should be identified for maintaining clinic supplies including vaccine. A list of clinic supplies should be kept on hand at the clinic site to be used for staff training, clinic set-up, and restocking. A list of suggested supplies is provided in Table 3.

7. TransportationDepending on circumstances (security concerns, parking facilities, clinic size and location, etc) the following groups may require transportation assistance: • Clinic staff, • High-risk, elderly and disabled individuals, or specific priority group • The general public (i.e., persons with lower or unknown risk of exposed).

In addition, transportation will be needed to keep adequate amounts of vaccine and various clinic supplies in stock. Pick-up locations for staff and supplies should be arranged and clearly communicated to drivers and staff.

Although transportation of clinic staff can be handled with agency motor pool or rented vans, special security arrangements may be required. Until vaccine supplies are no longer critical, vaccine can be transported in law enforcement or similar secure vehicles. If transportation of large numbers of vaccine clients is required, public and/or private buses may needed. In these cases, a hotline or other mechanism must be established to enable individuals to obtain information about bus departure locations and schedules. Special consideration should be given if transportation of special populations becomes necessary [e.g., children, the elderly, homeless persons, remote populations, and disabled (including homebound) persons. The ability to communicate with drivers via radio or cell phones is critical.

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TABLE 3PANDEMIC INFLUENZA CLINIC SUPPILIES AND EQUIPMENT

General Supplies and Equipment Vaccine Administration Supplies Emergency Supplies

TablesChairsWater and cupsPaperPen, pencilsEnvelopesRubber bandsTapeStapler/staplesScissorsPost-it NotesClipboardsFile boxesTelephone/Cell phonesPaper towelKleenex tissueTable pads/clean paper Trash containers/bags ID badges for staffList of emergency phone numbers

Cooler/refrigerator for vaccineNeedlesSyringes“Sharps” containersLatex glovesLatex-free glovesAntibacterial hand-washing solutionsAlcohol wipesRectangle band-aidsGauzeAdhesive tape Spray bottle of bleach solution

Standing orders for emergenciesEpinephrine 1:1000 SQDiphenhydramine 50 mg IM3cc syringes with 1”, 25-guage needles1.5’ needlesTuberculin syringes with 5/8” needles (for epinephrine)Alcohol wipes/Sterile dry padsBandagesTongue depressorsAdult and pediatric pocket masks with one way valveAdult and pediatric airways tubesTourniquetGurneyStethoscopeFlashlight/batteriesBlood Pressure MonitorInstant Cold PacksCotsBlanketsPillows

Crowd Management Supplies

Signs for clinic stations and between stations

Queue partitions (to keep people in lines), roping

Computer Equipment and Supplies

ComputersPrinters/Ink CartridgesPaperInternet access

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8. Vaccine Storage and HandlingGuidelines for handling and storage of inactivated and live-attenuated influenza vaccines are appended. The package inserts should be consulted for optimal cold storage criteria. For both types of vaccine, the cold storage temperature recommendations for vaccine refrigerators, shipping containers and day storage at administration sites is 2-8° C. Vaccine shipping boxes and equivalent containers and cold gel packs are adequate for day use. If the clinic lasts for more than one day, arrangements must be used to store the vaccine in a secure, temperature-monitored refrigerator. Vaccine usage should be monitored closely, and arrangements made to obtain additional vaccine, as needed.

9. Disposal of Needles and Medical SuppliesAll vaccination operations should observe universal precautions for preventing blood exposures and blood borne pathogen transmission (i.e., hepatitis B and C viruses [HBV, HCV], and human immunodeficiency virus [HIV]). Specific guidelines for the proper disposal of instruments and other potentially contaminated material during a novel H1N1 influenza vaccination operation are summarized below:

1. Appropriate disposal of pre-sterilized needles after use: • Medical waste sharps containers should be available in the area where the sharp is used. • Arrangement should be in place for transport and destruction of filled sharps containers.

Other medical waste, including gauze or cotton used during administration of vaccine, other potentially contaminated material, and empty vaccine vials and nasal spray containers should be bagged in appropriately marked biohazard bags and incinerated or autoclaved on-site if possible

10. Vaccine Security and TrackingSince the demand for influenza vaccine for novel H1N1 may be very high, care must be taken to protect the vaccine supply from theft and fraud. In addition, great care and pre-planning must occur to minimize vaccine wastage that may result from improper handling and storage, and discarding prefilled syringes and partially used vials. Because of these factors, each and every dose and vial should be accounted for before and after each clinic session.

11. Communication SystemsEach clinic must have a working phone and computer facilities for e-mail traffic. If available, walkie-talkies and cell phones should be distributed to the clinic staff. Ideally, replacement batteries and/or battery chargers for each device also should be made available. A list of important land and cell phone numbers should also be distributed to all clinic staff.

12. Post Clinic ActivitiesPost-clinic activities are necessary to ensure that the event is documented for the public record, to determine the cost of the operation and to enhance efficiency for future efforts. In this context, evaluation of novel H1N1 influenza clinics should include review of expenditures and in-kind cost incurred in the operation, identification of gaps and problems, recommended changes in emergency response plans, and a description of implications for public health infrastructure.

CS204940-D